Study of Ipilimumab and Dasatinib Combination Therapy in Patients With Chronic or Accelerated Chronic Myeloid Leukemia

Phase Ib Study Evaluating the Safety and Exploring the Molecular and Cytogenetic Response of Combination Therapy With Dasatinib and Ipilimumab in Patients With Chronic or Accelerated Phase Chronic Myeloid Leukemia

The purpose of the study is to assess the safety of ipilimumab and dasatinib combination therapy in patients with CML

Study Overview

• Status: Withdrawn
• Conditions: Leukemia, Myeloid, Chronic
• Intervention / Treatment: Biological: Ipilimumab

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas, M.D. Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ph+ CML on dasatinib therapy
• Loss of cytogenetic or molecular response while on dasatinib therapy
• On stable dose of dasatinib for a minimum of 12 weeks and with < 14 day interruption of treatment

Exclusion Criteria:

• Blast crisis CML
• Autoimmune disease
• Uncontrolled or significant cardiovascular disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 and Group 2	Biological: Ipilimumab; IV Solution, IV, 10 mg/kg, (if dose reduction necessary at 3 mg/kg), Every three weeks for the first 10 weeks, with a booster at week 22, Up to 38 weeks depending on response; Other Names: BMS-734016; MDX-010

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the safety of ipilimumab in combination with dasatinib in CML patients with a loss of previously achieved major molecular response or a loss of previously achieved cytogenetic response to dasatinib	At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the frequency of molecular response, complete cytogenetic response and an overall efficacy signal response rate	At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
To explore the immunologic responses to combination therapy with ipilimumab and dasatinib	At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
To explore whether molecular responses to combination therapy with ipilimumab and dasatinib correlate with immunologic responses	At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Anticipated): February 1, 2011
• Study Completion (Anticipated): February 1, 2011

Study Registration Dates

• First Submitted: August 7, 2008
• First Submitted That Met QC Criteria: August 7, 2008
• First Posted (Estimate): August 11, 2008

Study Record Updates

• Last Update Posted (Estimate): February 17, 2016
• Last Update Submitted That Met QC Criteria: February 16, 2016
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Ipilimumab
• Other Study ID Numbers: CA184-033